(672 days)
Not Found
No
The summary describes a device with manual controls for setting parameters like frequency, intensity, and time. There is no mention of AI, ML, or any automated decision-making or data processing that would indicate the use of such technologies. The device appears to be a straightforward infrared light therapy system with user-controlled settings.
Yes
The device is intended to treat specific medical conditions, such as pain, spasms, stiffness, and joint aches, by providing therapeutic benefits like increased blood circulation and muscle relaxation. These are typical characteristics of a therapeutic device.
No
The device description and intended use do not mention any diagnostic capabilities. It is described as a light therapy system for pain relief and increased blood circulation.
No
The device description explicitly states it is a "Light Therapy System" that uses "infrared light emitting diodes" and "front panel controls and display," indicating it is a hardware device that emits energy.
Based on the provided information, the MB System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as emitting infrared energy to provide therapeutic benefits like increased blood circulation, pain relief, and muscle relaxation. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details the device's function as applying topical heat using infrared LEDs. This aligns with a physical therapy or pain management device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) or to provide information about a patient's health status based on such examination.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens and provide diagnostic information. The MB System operates in vivo (on the body) for therapeutic purposes.
N/A
Intended Use / Indications for Use
The MB System is a device that emits energy in the infrared spectrum to provide temporary increase in local blood circulation, temporary relief of muscle pain. spasms and stiffness, temporary relief of minor pain and joint aches associated with arthritis, and relaxation of muscles.
Product codes
ILY
Device Description
The MB BioEnergy Light Therapy System provides easy to use front pancl controls and display for the operation of an array of infrared light emitting diodes that can apply topical heat to areas of the patient body. The user can set the frequency of oscillation, intensity level, and time of operation to control delivery of the radiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
areas of the patient body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
0
030275 1/2
NOV 2 9 2004
510(k) Summary
1. Applicant
Amest Corporation 30394 Esperanza Rancho Santa Margarita, CA 92688 Contact person: John Iest Amest Corporation 30394 Esperanza Rancho Santa Margarita. CA 92688 949-766-9692 ext 11 Date prepared: August 31, 2004
2. Device name
| Proprietary name: | MB BioEnergy Light Therapy System |
|---|---|
| Common name: | Light Therapy System |
| Classification: | Infrared lamp (21 CFR 890.5500) |
| Product Code: | ILY |
3. Substantially Equivalent Devices
| 1. K020017 - | MedX Health Corp. MedX 1000 Series Infrared Lamp |
|---|---|
| 2. K014208 | Russian American Technology Associates, Inc., SSIR Lamp |
4, Device Description:
The MB BioEnergy Light Therapy System provides easy to use front pancl controls and display for the operation of an array of infrared light emitting diodes that can apply topical heat to areas of the patient body. The user can set the frequency of oscillation, intensity level, and time of operation to control delivery of the radiation.
5. Intended use:
The MB System is a device that emits energy in the infrared spectrum to provide temporary increase in local blood circulation, temporary relief of muscle pain. spasms and stiffness, temporary relief of minor pain and joint aches associated with arthritis, and relaxation of muscles.
6. Comparison of technological characteristics with predicate device:
The MB BioEnergy Light Therapy System and the MedX 1000 Series and the SSIR System all use LEDs to provide IR energy to generate topical heating to clevate temperature. The treatment from all of these devices is designed to provide relief of muscle pain and strains. All devices have the same method of treatment, have similar indications for use, and provide the same general controls for administration of topical heating.
1
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7. Conclusion
The MB BioEnergy Light Therapy System is substantially equivalent to the predicate devices, has been tested to support compliance with industry standards, and therefore raises no new issues of safety or efficacy.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an eagle-like emblem with three stylized lines representing the bird's body and wings. The emblem is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 9 2004
Mr. John Iest President Amest Corporation 30394 Esperanza Ranch Santa Margarita, California 92688
Re: K030275
Trade/Device Name: MB BioEnergy Light Therapy System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: II Product Code: ILY Dated: August 30, 2004 Received: August 31, 2004
Dear Mr. lest:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. John Iest
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Muriam C. Provost
C.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K030275
Device Name: MB BioEnergy Light Therapy System
Indications for Use:
The MB System is a device that emits energy in the infrared spectrum to provide temporary increase in local blood circulation, temporary relief of muscle pain, spasms and stiffness, temporary relief of minor pain and joint aches associated with arthritis, and relaxation of muscles.
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
Division of General, Restorative, and Neurological Devices
510(k) Number K036275